Quick answers
- What is Glyburide and metformin hydrochloride used for?
- The FDA-approved label (Glyburide and Metformin Hydrochloride, Bryant Ranch Prepack, August 18, 2026) says: “Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Glyburide and metformin hydrochloride have a boxed warning?
- Yes. The FDA label for Glyburide and Metformin Hydrochloride has a boxed warning (“WARNING: LACTIC ACIDOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Glyburide and metformin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Glyburide and metformin hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Glyburide and metformin hydrochloride?
- 10 companies list prescription products of Glyburide and metformin hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Preferred Pharmaceuticals Inc. and Bryant Ranch Prepack.
What Glyburide and metformin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
— FDA label: Glyburide and Metformin Hydrochloride, Bryant Ranch Prepack, effective August 18, 2026. Read the full label on DailyMed →
The FDA has 19 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LACTIC ACIDOSIS
. Read it on the full label →
19 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 30 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| glyburide 2.5 mg · metformin hydrochloride 500 mg tablet | Generic | $0.1606 per tablet |
| glyburide 2.5 mg · metformin hydrochloride 500 mg tablet, film coated | Generic | $0.1606 per tablet |
| glyburide 5 mg · metformin hydrochloride 500 mg tablet | Generic | $0.1899 per tablet |
| glyburide 5 mg · metformin hydrochloride 500 mg tablet, film coated | Generic | $0.1899 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions4 products
- Preferred Pharmaceuticals Inc.4 products
- Bryant Ranch Prepack4 products
- Rising Pharma Holdings, Inc.3 products
- Aurobindo Pharma Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- NuCare Pharmaceuticals, Inc.2 products
- Northwind Health Company, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA077870Aurobindo Pharma · November 14, 2007
- ANDA079009Heritage · June 3, 2009
- ANDA206748Zydus Pharms · February 29, 2016
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 861743, 861748, 861753 |
|---|---|
| SPL set ID of the quoted label | 4dcef36f-000e-43f5-8d67-0e2a079ab2c6 |
| FDA labels (SPL) | 19 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | GLYBURIDE / METFORMIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Glyburide and Metformin Hydrochloride, Bryant Ranch Prepack, effective August 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →